The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Prometheus Chitogauze Xr Pro.
| Device ID | K153582 |
| 510k Number | K153582 |
| Device Name: | Prometheus ChitoGauze XR PRO |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON MEDICAL TECHNOLOGIES, INC. 720 SW WASHINGTON STREET, SUITE 200 Portland, OR 97205 |
| Contact | Maire Ni Beilliu |
| Correspondent | Maire Ni Beilliu HEMCON MEDICAL TECHNOLOGIES, INC. 720 SW WASHINGTON STREET, SUITE 200 Portland, OR 97205 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-15 |
| Decision Date | 2016-05-25 |
| Summary: | summary |